Induction Preoperative Chemotherapy for Patients With Locally Advanced Triple Negative Breast Cancer

Triple Negative Breast Cancer Clinical Trial

Official title:

Phase 2 Study of Two Consequent Chemotherapy Regimens as Induction Preoperative Therapy for Patients With Locally Advanced Triple Negative Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969032
• Other study ID #: LATN-2ICR
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2013
• Last updated: November 4, 2014
• Start date: August 2011
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Russian Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to increase survival of patients with locally advanced triple-negative breast cancer using two consequent induction preoperative chemotherapy regimens.

Description:

Compared to other breast cancer subtypes, patients with triple-negative breast cancer have a lower recurrence-free and overall survival, regardless of disease stage at diagnosis. That's why new approaches to treatment of this aggressive breast cancer subtype are extremely anticipated.

One of the ways to improve the results of treatment of locally advanced triple-negative breast cancer is intensification of induction preoperative chemotherapy regimens. Elevation of the rate of pathological complete responses after completion of intensification induction preoperative chemotherapy enables to decrease the stage and increase survival of this aggressive breast cancer subtype. We hope to achieve more clinical and pathological treatment responses than with standard chemotherapy regimens and therefore to improve treatment outcomes of this extremely adverse group of patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Female patients, age =18 years=75

• Histologically confirmed invasive ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma of the breast

• Stages ?2-4 N 2-3 M0

• Signed inform consent

Exclusion Criteria:

• Previous treatment for this breast cancer

• History of malignancy treated with curative intent within the previous 5 years with the exception of skin cancer, cervical carcinoma in situ, or follicular thyroid cancer. Patients with previous invasive cancers (including breast cancer) are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease

• Pregnancy or breast-feeding

• Serious concurrent diseases or conditions that may alter chemotherapy conduction

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine
Paclitaxel 60 mg/m2 IV weekly plus Carboplatinum AUC2 IV weekly for 9 weeks, then Doxorubicin 25 mg/m2 IV weekly plus Endoxan 50 mg per os q.i.d. plus Capecitabine 500 mg t.i.d for 9 weeks

Locations

Country	Name	City	State
Russian Federation	Russian Cancer Research Center named after N.N.Blokhin RAMS	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Russian Academy of Medical Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with 3/4 Grade CTC adverse events to assess toxicity and tolerability of the chemotherapy regimens		After 18 weeks os induction chemotherapy	Yes
Primary	The pathological complete response rate to two consequent induction preoperative chemotherapy regimens		After 18 weeks of induction chemotherapy	No
Secondary	Disease-free survival		3 years	No

External Links

•   Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine
•   Triple Negative Locally Advanced Breast Cancer, Induction Chemotherapy